Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant

NCT02326675 | Terminated

• 1 other identifier: IRB201400628
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Oral mucositis is a common complication of cancer therapy. Mucositis results from damage to the mucosal epithelium after delivery of chemotherapy or radiation treatments designed to treat the cancer. A number of treatment factors have been shown to influence the incidence and severity of mucositis, including chemotherapy type and dosage. High-dose chemotherapy before stem cell transplantation can cause severe oral mucositis and is often the side effect that patients find the most difficult to endure. Cryotherapy, keeping ice chips in the mouth during chemotherapy infusion, has been shown to prevent or alleviate mucositis caused by high-dose melphalan alone or given in combinations used in pre-transplant conditioning. One other drug notorious for causing severe mucositis is etoposide (VP-16). The specific aims of the study are: 1) to assess tolerability of cryotherapy given during chemotherapy administration; 2) to determine the efficacy of cryotherapy in reducing etoposide-induced mucositis.

Conditions

Mucositis; Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation; Stomatitis

Keywords

Etoposide; Cryotherapy

Outcome Measures

Primary Outcomes (2)

• Number of participants that tolerate cryotherapy during each etoposide infusion

  Up to seven days prior to stem cell transplant.

• Time to onset, severity and duration of mucositis following etoposide administration

  Participants will be followed starting on Day +1 post-transplant until they are discharged from the hospital, an expected average of 3-4 weeks.

Study Arms (2)

Cryotherapy Group (Group A)

ACTIVE COMPARATOR

Subjects in the intervention group will receive both standard oral care and cryotherapy. During the 30 minute cryotherapy periods, subjects will eat ice chips, and/or consume very cold or frozen foods. Cryotherapy will begin 15 minutes prior to the start time of each etoposide infusion. After 30 minutes of cryotherapy, subjects will begin the saline rinses. The subject should perform 3 saline rinses over 15 minutes. After 15 minutes of saline rinses, the 30-minute cryotherapy / 15-minute saline rinse cycles will be repeated until 30 min after completion of etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.

Other: Ice

Standard Oral Care Group (Group B)

ACTIVE COMPARATOR

Subjects in the control group will receive standard oral care only. At the beginning of each etoposide infusion, the subject will begin the saline rinses. The subject will perform 3 saline rinses over 15 minutes followed by 30 minutes of rest (no rinses). The 15-minute saline rinse / 30-minute rest cycles will be repeated until 30 minutes after the completion of the etoposide infusion (approximately 150 minutes). In addition, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators.

Other: Normal Saline Solution

Interventions

Ice OTHER

This group will receive cryotherapy, saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.

Also known as: Cryotherapy,Ice Chips

Cryotherapy Group (Group A)

Normal Saline Solution OTHER

This group will receive saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.

Standard Oral Care Group (Group B)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 18 year old or older who are eligible candidates for myeloablative autologous stem cell transplantation (ASCT).
• Subjects receiving etoposide as part of their conditioning regimen with a planned total dose of ≥ 30 mg/kg.

You may not qualify if:

• Subjects with prior radiation to head \& neck region.
• Subjects with known oropharynx involvement with their malignancy.
• Subjects with a history of non-compliance or who lack capacity to give informed consent.

Sponsors & Collaborators

• University of Florida: lead
• University of Florida Health: collaborator

Study Sites (1)

UF Health Shands Cancer Hopsital

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Mucositis; Stomatitis

Interventions

Ice; Saline Solution

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jamie Dees, RN

  UF Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 29, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

US (1)